Full Description
Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health.
This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science.
Contents
Section I. Fundamental Principles
1. Introduction to Clinical Research
2. Patient-Oriented Research
3. Clinical Trials
4. Introduction to Epidemiology
5. The Patient-Centered Outcomes Research Institute: Current Approach to Funding Clinical Research and Future Directions
6. Health-Care Technology Assessment (HTA)
7. Health Services Research: Translating Discovery and Research Into Practice and Policy
Section II. Approaches
8. Measurement of Biological Materials
9. Imaging Tools in Clinical Research: Focus on Imaging Technologies
10. Imaging Tools in Human Research: Focus on Image-Guided Intervention
11. Nanotechnology in Clinical and Translational Research
12. The Use of Questionnaires and Surveys
13. Information Technology
14. Principles of Biostatistics
15. Good Clinical Practice and Good Laboratory Practice
Section III. Human Genetics
16. Introduction to Human Genetics
17. Epidemiologic and Population Genetic Studies
18. Pharmacogenetics of Drug Metabolism
19. Statistical Techniques for Genetic Analysis
Section IV. Human Pharmacology
20. Introduction to Clinical Pharmacology
21. Adverse Drug Events
Section V. Societal Context of Human Research
22. Translating Science to the Bedside: The Innovation Pipeline
23. Regulatory Environment
24. Ethical Issues in Translational Research and Clinical Investigation
25. Clinical Research in the Public Eye
Section VI. Research in Special Populations
26. Research in Special Populations: Acute Illnesses; Critical Care; and Surgical Patients
27. Research in the Emergency Care Environment
28. Psychiatric Disorders
29. Research in Special Populations: Geriatrics
30. Clinical Research in Neurology
31. Research in Pediatrics
32. Cancer as a Paradigm for Translational and Clinical Biomedical Research
33. Maintaining an Emphasis on Rare Diseases With Research Initiatives and Resources at the National Center for Advancing Translational Sciences
Section VII. Infrastructure
34. Clinical and Translational Science Infrastructure
Section VIII. Education, Training and Career Choices
35. Education, Training and Career Choices: Training Basic, Clinical, and Translational Investigators
36. A Stepwise Approach to a Career in Translational Research
37. Physician Careers in the Pharmaceutical Industry
Section IX. Research in Academia
38. Industry-Sponsored Clinical Research in Academia
39. Governmental Support of Research
40. The Role of Nonprofit, Nongovernmental Funding in Support of Biomedical Research
41. Modern Drug Discovery and Development
42. Pharmaceutical and Biotechnology Sector Support of Research
Section X. Prospectus
43. The Future of Clinical Research
